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Effect of Fingolimod with and without probiotic and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis

Effect of Fingolimod with and without probiotic and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120215009014N335
Enrollment
80
Registered
2020-01-20
Start date
2020-04-03
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group 1: Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and LactoCare probiotic capsule (manufactured by Pardis Technology Park Co.) daily for

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age of 20 to 40 years, Relapsing-remitting multiple sclerosis, Taking Fingolimod for at least 6 to 9 months,

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding, Immunodeficiency, History of abdominal surgery or short bowel syndrome, The risk of mesenteric ischemia, History of TB or HIV, Hepatitis and liver disease, Diabetes, Kidney diseases, High blood pressure

Design outcomes

Primary

MeasureTime frame
Hepatic complication. Timepoint: Before and 2 months after the intervention. Method of measurement: With liver function tests (ALT, AST).—

Secondary

MeasureTime frame
Gastric complication. Timepoint: Before and 2 months after the intervention. Method of measurement: By taking history.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Ahmadi

Hamedan University of Medical Sciences

fatemeh.ahmadi13731397@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026